Overtube and operative procedure via bodily orifice

ABSTRACT

An overtube includes an insertion portion that has a distal end portion and a proximal end portion, and at least the distal end portion thereof is inserted into a subject; a first lumen that is formed in the insertion portion and that allows freely inserting and removing a device for carrying out medical procedures in the subject; puncture needles that pass through the insertion portion, have a control member connected to the proximal end portion of the insertion portion, and puncture tissue; and second lumens that are provided in the insertion portion and through which puncture needles are passed, the second lumens having on the distal end portion of the insertion portion openings through which distal ends of the puncture needles extend and retract, and the openings being provided on an inside of the insertion portion defined by the first lumen.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an overtube and a method for a medicalprocedure through a natural orifice using the same.

2. Description of the Related Art

When carrying out medical procedures such as observation and treatmentof the internal organs of the human body, laparotic operation is knownin which, instead of forming a large incision in the abdominal wall, aplurality of openings are formed in the abdominal wall, instruments suchas a laparoscope and forceps are inserted into respective openings, andthe procedure is carried out. In this type of operation, because onlyforming small openings in the abdominal wall is necessary, there is theadvantage in that the burden on the patient becomes small.

Over the past few years, a method for further reducing the burden onpatients has been proposed wherein a procedure is carried out byinserting a flexible endoscope through a natural orifice of the patient,such as the mouth, nose, or rectum. An example of such a procedure isdisclosed in U.S. Pat. No. 5,458,131.

In this method, a flexible endoscope is inserted through the patient'smouth, an incision is formed in the stomach wall, and the distal portionof the endoscope is passed into the abdominal cavity through thisopening. In addition, while using the endoscope as an apparatus toobserve the inside of the abdominal cavity, the desired procedure iscarried out in the abdominal cavity by using instruments that are passedthrough the endoscope or instruments that are inserted through anotheropening.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an apparatus and methodthat enables carrying out more easily the incision of tissue whencarrying out medical procedures using an overtube.

An overtube according to a first aspect of the present invention has aninsertion portion that has a distal end portion and a proximal endportion, and at least the distal end portion thereof is inserted into asubject; a first lumen that is formed in the insertion portion and thatallows freely inserting and removing a device for carrying out medicalprocedures in the subject; puncture needles that pass through theinsertion portion, have a control member connected to the proximal endportion of the insertion portion, and puncture tissue; and second lumensthat are provided in the insertion portion and through which punctureneedles are passed, the second lumens having on distal end portion ofthe insertion portion openings through which distal ends of the punctureneedles extend and retract, and the openings being provided on an insideof the insertion portion defined by the first lumen.

An overtube according to a second aspect of the present invention has aninsertion portion that has a distal end portion and a proximal endportion and that has formed therein a first lumen that allows insertingand removing a device for carrying out medical procedures in a subject,and at least the distal end portion thereof is inserted into a subject;puncture needles that puncture tissue pass through the insertion portionand that have a control member connected to the proximal end portion ofthe insertion portion; and second lumens that are provided in theinsertion portion and through which puncture needles pass, the secondlumens having on the distal end portion of the insertion portionopenings through which distal ends of the puncture needles extend andretract, and the openings being provided on an inside of the insertionportion that forms the first lumen.

An method for a medical procedure through a natural orifice according toa third aspect of the present invention includes: inserting an overtubethrough a natural orifice of a subject, the overtube having a lumenformed therein that allows passage of a device; projecting the punctureneedles that is passed through the overtube from an inside of theovertube defined by the lumen; and puncturing tissue by the punctureneedles while observing the puncture needles by using an observationapparatus inserted into the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing showing the entire overtube according to afirst embodiment.

FIG. 2 is a drawing showing the essential portions of the overtubeaccording to a first embodiment.

FIG. 3 is a perspective view showing the distal end of the overtubeaccording to a first embodiment.

FIG. 4A is a cross-sectional view along III-III in FIG. 3.

FIG. 4B is a cross-sectional view along IV-IV in FIG. 3.

FIG. 5 is a partial enlarged cross-sectional view showing the electrodecontrol portion of the overtube according to a first embodiment.

FIG. 6A is an overall view showing the two-armed T bar used in thepresent embodiment.

FIG. 6B is a cross-sectional view showing the state in which the two-armbar is mounted on the puncture needle of the overtube according to afirst embodiment.

FIG. 7 is a partial cross-sectional view showing the needle controlportion of the overtube according to a first embodiment.

FIG. 8 is a cross-sectional view of the vicinity of the endoscope lockbutton of the overtube according to a first embodiment.

FIG. 9 is an overall schematic view of the endoscope showing an exampleof the device used in the overtube according to a first embodiment.

FIG. 10 is a flowchart showing the medical procedure according to afirst embodiment.

FIG. 11 is a drawing for explaining the state in which the endoscope isinserted into the overtube during a medical procedure according to afirst embodiment.

FIG. 12 is a drawing for explaining the state in which the overtube isintroduced into the targeted incision site during a medical procedureaccording to a first embodiment.

FIG. 13 is a drawing for explaining the state in which a portion of thestomach wall is sucked into the overtube in a medical procedureaccording to a first embodiment.

FIG. 14 is a drawing for explaining the state in which the abdominalcavity is insufflated by feeding air from an injection needle during amedical procedure according to a first embodiment.

FIG. 15 is a drawing for explaining the state in which the suckedstomach wall is punctured by the puncture needles of the overtube in amedical procedure according to a first embodiment.

FIG. 16 is a drawing for explaining the state in which the anchors ofthe two-armed T bar are ejected from the puncture needles during amedical procedure in a first embodiment.

FIG. 17 is a drawing for explaining the state in which an incision ismade in the sucked stomach wall by a cutting electrode of the overtubeduring a medical procedure according to a first embodiment.

FIG. 18 shows FIG. 17 after being rotated by 90°.

FIG. 19 is a drawing for explaining the state in which the endoscope hasbeen inserted into the abdominal cavity during a medical procedureaccording to a first embodiment.

FIG. 20 is a drawing for explaining the state in which the suture of theretained two-armed T bar is pulled and bound during a medical procedureaccording to a first embodiment.

FIG. 21 is a frontal view of the distal end portion showing a modifiedexample.

FIG. 22 is a cross-sectional view along the V-V line in FIG. 21.

FIG. 23 is a drawing showing the essential portions of the overtubeaccording to a second embodiment.

FIG. 24 is a cross-sectional view along line A-A in FIG. 21.

FIG. 25 is a flowchart for a medical procedure according to a secondembodiment.

FIG. 26A is a drawing for explaining the state in which the endoscopeinsertion portion projects from the overtube during a medical procedureaccording to a second embodiment.

FIG. 26B is a drawing for explaining the state in which the overtube ismoved from the state shown in FIG. 26A within the abdominal cavity byusing a second magnet of the overtube, where the endoscope insertionportion acts as a guide.

FIG. 27A is a drawing for explaining the state in which the endoscopeinsertion portion and the overtube both project from the opening duringa medical procedure according to a second embodiment.

FIG. 27B is a drawing for explaining the state in which the endoscopeinsertion portion and the overtube are moved within the abdomen from thestate shown in FIG. 27A by using a second magnet of the overtube.

FIG. 28 is a drawing for explaining the state in which the overtube issupported inside the abdomen by using a first magnet of the overtubeduring a medical procedure according to a second embodiment.

FIG. 29 is a drawing for explaining the state in which the direction ofthe overtube in the abdominal cavity is changed by using a first magnetand a third magnet of the overtube during a medical procedure accordingto a second embodiment.

FIG. 30 is a perspective view in which a scale and a scale-detectingmember are provided on the proximal handle.

FIG. 31 is a drawing for explaining the operation of the scale-detectingmember.

FIG. 32 is a cross-sectional view showing an example of a modificationin which the needle lumens are established along the inside perimeter ofthe lumen.

DETAILED DESCRIPTION OF THE INVENTION

The embodiments are explained in detail below. Note that below,identical structural elements are denoted by identical referencenumerals, and redundant explanations thereof are omitted.

First Embodiment

The overtube 1 according to the present embodiment provides a deviceinsertion portion which is inserted into the body of a subject of anexamination, and is used as a guide tube when inserting into the body adevice such as an endoscope (in order to simplify the explanation, inthe following explanation this may simply referred to as a “device” oran “endoscope”) for performing medical procedures in the body. Note thatthe content of the medical procedures may include a variety ofprocedures, such as suturing, observation, incision, and cellaspiration. More specifically, other examples include the observation ofthe abdominal organs, biopsies of the liver and pancreas, cauterizingmyoma of the uterus and liver (and other organs), contraceptivetherapies, extracting the appendix and gallbladder, and obesityoperation.

As shown in FIG. 1, this overtube 1 has an insertion portion 5 that hasa first lumen 3 having a distal end that opens in the direction ofinsertion into the subject and into which an endoscope 2, which is anexample of a device that extends in an axial direction, is inserted soas to be freely removable, and is inserted into a luminal organ such asthe stomach or the abdominal cavity of a patient; a cutting electrode(tissue cutting portion) 6 that traverses the distal end side of thefirst lumen 3 and, in the traversing state, is releasably disposed inthe insertion portion 5, and cuts the body tissue of the patient;electrode controlling wires (controlling members) 7A and 7B that areeach connected to the cutting electrode and disposed so as to be freelyextendable and retractable in the insertion portion 5; a electrodecontrolling portion (operating portion) 8 that extends or retracts theelectrode controlling wires 7A and 7B in the first lumen 3; and a needlecontrol portion 10 for controlling the puncture needles 32A and 32B andthe pushers 35 described below. Note that in this embodiment, thecutting electrode 6 and the electrode controlling wires 7A and 7B areformed by one wire. However, the cutting electrode 6 and the electrodecontrolling wires 7A and 7B may be formed by separate members andconnected together.

As shown in FIG. 2, the insertion portion 5 is elongated and flexible,and like a typical flexible endoscope, a bending portion 13 is providedat the distal end side of the insertion portion 5. In the bendingportion 13, a plurality of segmenting rings 11 are connected along thebending wires 12. Here, a bending portion 13 that is actively bent bythe operation of the operator is not provided. Rather the insertionportion may be formed in the shape of a flexible tube and passively bentby following the bent shape of a device such as an endoscope. As shownin FIG. 3, a short tubular distal end portion 15 is provided farthertoward the distal end than the bending portion 13. The distal end 15 isformed by a substantially colorless transparent material such aspolycarbonate, and the visibility is improved thereby in comparison tothe case of being manufactured by an opaque material. Note that thedistal portion of the distal end portion 15 (the portion of the distalend at which the opening of the first lumen 3 is formed) forms anabutting portion 15B that abuts the tissue.

The cutting electrode 6 is a wire made, for example, of stainless steeland capable of high frequency conduction. During an incision in whichthe tissue is cut (first state), the cutting electrode 6 is disposed soas to traverse the center portion of the first lumen 3 in a directionperpendicular to the axial direction of the insertion portion 5. Thelength of the cutting electrode 6 is formed so as to be longer than theinner diameter of the first lumen 3. That is, as shown in the state ofuse in FIG. 3, one end of the cutting electrode 6 is disposed in thefirst inner groove 16 that is formed in the outer edge of the firstlumen 3 (in other words, the inner peripheral surface or inside of thedistal portion 15 that defines the first lumen 3), which is the innersurface of the distal end portion 1. The other end of the cuttingelectrode 6 is disposed in the second inner groove 17 formed in theouter edge (in other words, the inner peripheral surface or inside ofthe distal end portion 15 that defines the first lumen 3) at asubstantially symmetrical position with respect to the first innergroove 16 across the center of the first lumen 3.

As shown in the accommodated state (second state) in FIG. 4, one end ofthe cutting electrode 6 is connected to the electrode controlling wire7A. The other end of the cutting electrode 6 is connected to theelectrode controlling wire 7B. Each of the electrode controlling wires7A and 7B passes so as to be freely extendable and retractable in theelectrode tubes 18, which consist of an insulator. The electrode tubes18 are routed through the inside of the insertion portion 5 from theproximal side. As shown in FIG. 4, the distal ends of the electrodetubes 18 abut the steps 16A and 16B formed in the corresponding innergrooves 16 and 17 of the distal end portion 15. In this embodiment, onewire is used for the cutting electrode 6 and the electrode controllingwires 7A and 7B, and the diameter of the portion that forms the cuttingelectrode 6 is formed so as to be narrower than the diameter of theportion that forms the electrode controlling wires 7A and 7B. However,this is not limiting, and the cutting electrode 6 and the electrodecontrolling wires 7A and 7B may be formed by separate members. Inaddition, the diameters of the cutting electrode 6 and the electrodecontrol wires 7A and 7B may be identical.

In the accommodation state shown in FIG. 4, the cutting electrode 6 isaccommodated in the accommodating portion 90 formed on the innerperipheral surface of the distal end 15. The accommodating portion 90 isa groove that is provided from the first inner groove 16 to the secondinner groove 17 along the peripheral direction. The end portion of theaccommodating portion 90 is disposed slightly closer to the distal endthan the steps 16A and 16B that abut the electrode tubes 18.

Note that, as shown in FIG. 1 and FIG. 5, there is one electrode tube 18at the proximal end that projects from the insertion portion 5, but inorder to accommodate the electrode controlling wires 7A and 7Bseparately in the insertion portion 5, the two wires are separated alongthe way and inserted into the insertion portion 5, and the distal endsare connected to the distal end portion 15. The proximal ends of theelectrode controlling wires 7A and 7B pass through the one rigidoperating pipe 19 that is disposed so as to project from the distal endof a control handle 21 described below.

The electrode controlling portion 8 has an control body portion 20 thatis connected to the proximal end of a electrode tube 18 and a controlhandle 21 that is disposed on the control body portion 20 so as to befreely extendable and retractable. A through hole 20 a is providedthrough which the electrode controlling wires 7A and 7B and theoperating pipe 19 are inserted. An engaging hole 20 b that engages therigid portion 18A, which is disposed at the proximal end of theelectrode tube 18, is formed on the distal end of the controlling bodyportion 20, and the electrode tube 18 is fastened to the engaging hole20 b by a screw 22. A finger grasping portion 20A is disposed at theproximal end of the control body portion 20.

A connecting plate 23 is disposed on the control handle 21, and iselectrically connected to the end portion of the electrode controllingwires 7A and 7B that have been passed through the operating pipe 19. Afastening screw 24 is disposed on the connecting plate 23, and byclamping the fastening screw 24 onto the connecting plate 23, theelectrode controlling wires 7A and 7B are fastened and electricallyconnected. The connecting plate 23 is electrically connected to theconnecting terminal 26A that is disposed on the control handle 21 viathe electric wiring 25. A connecting terminal 26B that is disposed onthe distal end of a power cord 28, which extends from the high frequencypower source 27, is fastened to and released from the connectingterminal 26A. A finger grasping portion 21A is also disposed on thecontrol handle 21.

As shown in FIG. 4B, on the inner peripheral surface 15A of the distalend 15 of the overtube 1, long holes 30 are each formed having a longaxis in the longitudinal direction (the direction that join the distalend and the proximal end of the insertion portion 5) of the distal endportion 15 in a position substantially perpendicular to the direction inwhich the first inner groove 16 and the second inner groove 17 areconnected. The long holes 30 serve as the distal end opening (theopening from which the puncture needles 32A and 32B project) of theneedle lumens 92 and 93 through which the puncture needles 32A and 32Bpass. In this embodiment, the center of the long holes 30 is providedmore toward the proximal end side than the distal end opening 3A of thedistal end portion 5. The long holes 30 communicate with the guideportions 91 that form the lumens through which the puncture needles 32Aand 32B pass, and the guide portions 91 are formed so as to inclineinside the distal end portion 15. The proximal end sides of the each ofthe guide portions 91 form conduits that communicate with the distalends of each of the needle lumens 92 and 93 formed on the proximal endportion of the distal end portion 15, thereby forming a second lumenalong with the needle lumens 92 and 93. The center axes of the needlelumens 92 and 93 are formed substantially parallel to the axis L3 (alsoreferred to as the center axis) of the first lumen 3, and are providedat opposing positions across the approximate center of the first lumen3, and are formed mutually parallel in their longitudinal direction. Theaxes (center axes) L1 of guide portions 91 are inclined inward (on theaxis of the first lumen (or on the center axis of the first lumen 3)) atan angle of 5° to 15° with respect to the axis of the needle lumens 92and 93. Note that the needle lumen 92 is provided at a location thatcrosses with the accommodating portion 90 for the cutting electrode 6described above. Therefore, the needle lumen 92 is partitioned into aportion 92A more toward the distal end side than the accommodatingportion 90 and a portion 92B that is more toward the proximal end sidethan the accommodating portion 90. The external sheaths 38 pass throughthe portion 92B and the needle lumen 93. The distal end of the externalsheaths 38 respectively abut the distal end portion of the needle lumen93 and the distal end portion of the portion 92B, and are therebyconnected and fastened.

The puncture needles (hollow needles) 32A and 32B pass through theinside of the external sheaths 38 so as to be freely extendable andretractable. Inside the puncture needles 32A and 32B, pushers 35 aredisposed so as to be freely extendable and retractable. One end of aflexibly deformable coil sheath is connected to the proximal end of thepuncture needles 32A and 32B, and pusher operating wires that operatethe pushers 35 pass inside the coil sheath. The other end of the coilsheath extends toward the proximal end side of the insertion portion 5,and communicates with a needle control portion 10.

As shown in FIG. 1 and FIG. 7, the needle control portion 10 has asheath grip portion 40 that is disposed so as to connect to the proximalends of the two external sheaths 38; a needle control handle 41 that isdisposed so as to connect to the proximal end of the two punctureneedles 32A and 32B that have been passed through the through holes 40 aprovided in the sheath grip portion 40 so as to be freely extendable andretractable; and a pusher connecting portion 43 that is connect to theend portions of the rod-shaped rigid portions 42 connected to theproximal end of the two pushers 35 that pass through the through holes41 a provided on the needle control handle 41 so as to be freelyextendable and retractable. The finger grasping portion 41A is providedin the needle control handle 41. Note that the needle control handle 41and the pusher connecting portion 43 may be partitioned into two suchthat the two puncture needles 32A and 32B and the two pushers 35 operateindependently of each other.

Here, a slit 32 a is formed at the distal ends of the puncture needles32A and 32B, and a rigid pressing member 35A is disposed on the distalend of the pushers 35. In the puncture needles 32A and 32B, as shown inFIG. 6B, anchors 33A of a two-arm T bar 33 are each held at a portionmore to the distal side than the pressing member 35A.

As shown in FIG. 6A, the two-arm T bar 33 has two sutures 33C that eachpass through one end side in a substantially triangular shaped stopper33B. In addition, the two sutures 33C may be formed by one thread. Inthis case, the large diameter portion 33Ca can be formed by tying a knotalong the one thread. Furthermore, a loop may be formed at the proximalend portion of this knot, and thereby the proximal end side is easilyretained by an instrument or the like. When formed by one suture, thereis the merit that the strength can be increased in comparison to thecase in which two sutures are tied together.

One end of the sutures 33C is formed into a large diameter portion 33Caby tying both end portions together. The anchors 33A are respectivelyfastened to the other ends of each of the sutures 33C. The anchors 33Ahave a cylindrical shape with a slit formed at the end portion, and thesutures 33C are passed in the longitudinal direction into the anchors33A through the slits of the anchors 33A. The large diameter portion33Ca having a diameter that is larger than the anchors 33A is formed onthe other end of the sutures 33C. The stopper 33B has a hole at thecenter of an elongated plate member in the longitudinal direction, andthe sutures 33C pass through this hole. Both end portions of the stopper33B in the longitudinal direction are bent back at an angle to fastenthe sutures 33C. Both end portions of the stopper 33B in thelongitudinal direction are cut into triangular shaped notches. Thestopper 33B fastens the sutures 33C by both end portions being bent backat an angle such that the notches intersect. Thereby, the sutures 33Cwill not fall out from between the end portions. When the large diameterportion 33Ca of the sutures 33C is pulled away from the stopper 33B,both end portions of the stopper 33B open slightly. Thereby, the stopper33B permits movement of the sutures 33C in this direction. In contrast,when a large diameter portion 33Ca of the sutures 33C on the anchor 33Aside is pulled, the sutures 33C move in the direction shown by the arrowin FIG. 6A. However, at this time, the sutures 33C do not move becauseboth end portions of the stopper 33B close to clamp the sutures 33C.

As shown in FIG. 6B, the pushers 35 are disposed inside each of thepuncture needles 32A and 32B so as to be freely extendable andretractable. As shown in FIG. 1, the stoppers 33B of the two-armed Tpart 33 are accommodated in a hole 37 (below, simply referred to as ahole) formed in the side surface of the insertion portion 5 from theproximal end side toward the distal end side.

As shown in FIG. 2, a proximal handle 44 having a diameter larger thanthe insertion portion 5 is disposed at the proximal end of the insertionportion 5 of the overtube 1. The proximal handle 44 has disposed thereona bending control lever 45 that is connected to the proximal end side ofthe bending wire 12 and carries out the bending control of the bendingportion 13; a bending lock lever 46 that fastens the position of thebending control lever 45 at an arbitrary position; and an endoscope lockbutton 47 that fastens the endoscope 2 in the first lumen 3 when theendoscope 2 is passed through the first lumen 3.

The distal end sides of the bending wires 12 are fastened to the distalend portion 15, and in this embodiment, two bending wires 12 passthrough the inside of the insertion portion 5, and the distal endsthereof are fastened at substantially opposing positions of the distalend portion 15 across the center of the first lumen 3. Note that in thisembodiment, two bending wires 12 are provided and the bending portion 13is formed so as to bend in two directions. However, this is notlimiting, and like the bending portions of well-known endoscopes, astructure may be used wherein four bending wires 12 and two bendingcontrol levers 45 are provided, and the bending portion bends in fourdictions.

As shown in FIG. 8, a broad pressing portion 47A is disposed at thedistal end of the endoscope lock button 47, and during normal usage, theendoscope lock button 47 is urged outward by the spring 48 in the radialdirection of the proximal handle 44. When it is necessary to insert andfasten the endoscope 2 inside the insertion portion 5, the endoscopelock button 47 is pressed inward in the radial direction, and therebythe pressing portion 47A presses the endoscope 2 so that the endoscope 2is relatively fastened due to friction. Note that alternately theendoscope lock button 47 may be pressed to release the friction. Inaddition, a mechanism may be provided in which the endoscope is lockedwhile the pressing portion 47A is pressed inward in the radialdirection, and the endoscope 2 and the insertion portion 5 aremaintained in a fastened state when the finger has removed from thepressing portion 47A.

As shown in FIG. 9, the endoscope 2 that has been inserted into thisovertube 1 is, for example, a flexible endoscope, and an elongatedflexible endoscope insertion portion 51 that is inserted into the bodyof a patient extends from the endoscope control portion 50, which isoperated by a technician. The endoscope distal end portion 52 of theendoscope insertion portion 51 can be bent by operating the angle knob53 disposed on the endoscope control portion 50. An observationapparatus 55, a distal end surface of an optical fiber 57 that guideslight from a light source apparatus 56 disposed outside the body, and adistal end opening of the channels 58 and 60 are provided in theendoscope distal end portion 52. The channel 58 is a passage that isconnected to a gas and water feeding apparatus 62 and a suctionapparatus 63 that are disposed outside the body via a universal cable61. The channel 58 is used for supplying and aspirating fluids withinthe body. In addition, the channel 60 is a passage for inserting andretracting instruments, and is disposed between the 6 o'clock and the 8o'clock positions of the endoscope insertion portion 51. Note that, forexample, two channels for the instruments may be provided, and theinvention is not limited to a single channel. Observation imagescaptured by the observation apparatus 55 are displayed on a monitor 66via a control portion 65.

Next, the operation of the present embodiment will be explained alongwith a method for a medical procedure through a natural orifice shown inthe flowchart in FIG. 10 using the overtube 1. Note that in thefollowing, the targeted incision site T is on the anterior wall of thestomach ST, and a procedure is explained in which a medical procedure iscarried by inserting the endoscope 2 through the mouth M of the patientPT into the stomach (abdominal organ) ST and then inserting theinsertion portion 5 of the endoscope 2 into the abdominal cavity ACthrough opening the stomach wall. In addition, in the embodimentexplained below, the endoscope 2 is inserted as a device through themouth M of the patient PT into the body, and the abdominal cavity AC isapproached by forming an opening SO in the anterior wall of stomach ST.However, the natural orifice into which the endoscope 2 is inserted isnot limited to the mouth M, and the natural orifice may be the rectum,nose, or the like. Furthermore, preferably an opening SO is formed inthe anterior wall of the stomach ST. However, this is not limiting, andan opening in the wall of a luminal organ (hollow organ) into which thedevice may be inserted as a natural orifice may be formed in anotherpart of the stomach ST, the esophagus, the small intestine, the largeintestine or the like.

First, as a preparatory step, the electrode controlling wires 7A and 7Bare passed through the electrode tubes 18, and the cutting electrode 6is disposed at the distal end portion 15. A jig (not illustrated) isinserted into the distal end opening 3A of the distal end portion 15 andthe cutting electrode 6 pressed and inserted into the accommodationportion 90. In this state, the puncture needles 32A and 32B are passedthrough the external sheath 38. As shown in FIG. 4A, the puncture needle32A traverses the accommodation portion 90, and the cutting electrode 6is disposed between the puncture needle 32A and the inner peripheralwall of the accommodation portion 90. The puncture needle 32A thattraverses the accommodation portion 90 serves as an engaging portion,and thereby the cutting electrode 6 is inhibited from projecting intothe first lumen 3. When this action has finished, the jig (notillustrated) is extracted.

When the medical procedure is carried out, the endoscope (device) 2 ispassed through the first lumen 3 disposed in the insertion portion 5 ofthe overtube 1, and the overtube 1 is inserted up to the proximal endside of the endoscope insertion portion 51. In this state, first theendoscope insertion portion 51 is inserted into the body of the patientPT, who is facing upwards, and next the overtube 1 is inserted into thebody to guide the endoscope insertion portion 51. In this manner, aninsertion step (S10) is carried out in which the insertion portion 5 ofthe overtube 1 and the endoscope 2 are inserted. By carrying out such aninsertion step, when the endoscope 2 is first inserted into the body, itis possible to insert the endoscope 2 alone into the body, and thus theinsertion characteristics are improved.

As shown in FIG. 11, a mouth piece 67 is affixed to the mouth of thepatient PT, and with the endoscope 2 inserted into the first lumen 3into the esophagus ES, the overtube 1 and the endoscope 2 are insertedthrough the mouth piece 67. Note that the cutting electrode 6 and thepuncture needles 32A and 32B do not project into the first lumen 3 ofthe distal end portion 15, and thus it is possible to preventinterference between cutting electrode 6, the puncture needles 32A and32B, and the endoscope 2. Then, when the overtube 1 and the endoscope 2are inserted into the body, it is possible to engage the cuttingelectrode 6 in advance on the inner surface of the first lumen 3. Whenthe endoscope 2 advances relative to the overtube 1, the cuttingelectrode 6 is not an obstruction, it is possible to project the distalend of the endoscope 2 from the overtube 1, and thereby thecharacteristics of insertion into the body are improved.

Next, as an insufflation step (S20), air is supplied to the stomach STvia the channel 58 of the insertion portion 5 from the air and waterfeeding apparatus 62 to distend the stomach ST.

Next, while confirming the targeted incision site T by using theendoscope 2, which also serves as an observation device, the processesmoves to a guidance step (S30) in which the insertion portion 5 of theovertube 1 is guided up to the targeted incision site T. First, afterthe endoscope insertion portion 51 of the endoscope 2 has been insertedinto the stomach, while observing the interior of the stomach ST via theobservation apparatus 55 disposed in the endoscope insertion portion 51,the distal end of the endoscope insertion portion 51 is brought up tothe targeted incision site T by operating the angle knob 53. Next, whileidentifying the targeted incision site T, using the endoscope insertionportion 51 as a guide, the insertion portion 5 of the overtube 1 ispressed, and as shown in FIG. 12, the distal end 15 of the overtube 1approaches in proximity to the targeted incision site T.

Next, the process proceeds to a needle moving step (S40) in which thepuncture needles 32A and 32B, which are disposed at the distal end sideof the insertion portion 5, are extended and retracted along the firstlumen 3. First, as a suction step (S41), while the distal end portion 15is abutted against the stomach wall so as to include the targetedincision site T, the stomach wall is sucked by the suction apparatus 63via the channel 58. At this time, as shown in FIG. 13, a portion of thestomach wall is sucked into the first lumen 3 of the distal end portion15 from the distal end opening 3A. Thereby, a space is establishedbetween the outer stomach wall and the abdominal cavity AC. Here, as adevice for sucking the stomach wall, a method in which the channel 58 ofthe endoscope 2 is used is not limiting. For example, a space formedbetween the inner surface of the first lumen 3 of the overtube 1 and theouter periphery of the insertion portion of a device such as anendoscope 2 that has been inserted into the first lumen 3 may be used asa suction passage, and a suction may be established by being attached toa suction apparatus 63. In this case, the suction effect may be furtherimproved by providing a valve (not illustrated) in the established spaceto inhibit the flow of fluids between the inside and outside of thebody.

Next, the process proceeds to a peritoneum insufflation step (S42).First, the peritoneum insufflation needle 68, which is connected to theair and water feeding apparatus 62, is inserted into the channel 60 ofthe endoscope 2. Then the distal end of the peritoneum insufflationneedle 68 is projected into the distal end portion 15, and as shown inFIG. 14, inserted farther up to the abdominal cavity AC by puncturingthe sucked stomach wall. Thereby, while the space between the suckedstomach wall and the abdominal wall AW is established, the stomach wallis punctured by the peritoneum insufflation needle 68, and thereby it ispossible to puncture only the stomach wall reliably. Next, air is passedinto the abdominal cavity AC via the peritoneum insufflation needle 68and the abdominal cavity AC is inflated so that the stomach ST and theabdominal wall AW are separated.

Preferably, the length of this peritoneum insufflation needle 68 isabout 12 mm, and more preferably, the distal end can be bent so as to beable to penetrate the center of the sucked stomach wall. In the case ofa bent injection needle, there is a bend at the distal end, and a bentwire (not illustrated) is installed that passes through the inside ofthe bend in the radial direction from the distal end toward the proximalside. Here, the channel 60 of the endoscope 2 is disposed between the 6o'clock and the 8 o'clock direction of the endoscope insertion portion51, and thus when the anterior wall of the stomach ST, the preferableincision position, is cut, the approach is from an upward angle.Therefore, the bent wire faces the center because the bend follows thecondition of the bending of the insertion portion 5 of the overtube 1,and thus by pulling the bent wire toward the proximal side, it ispossible to puncture the center of the stomach wall reliably. Inaddition, when using a normal injection needle without a bendingcapacity, the bending control of the endoscope 2 is carried out in theovertube 1, and the injection needle thereby faces the middle. Note thatduring insufflation, the inside of the abdominal cavity AC may bemaintained at an appropriate pressure by a feed gas pressure monitor andautomatic control.

Next, the process proceeds to a retention step (S43). Here, first thesheath grip portion 40 is grasped, and the needle control handle 41 isadvanced in the direction of the sheath grip portion 40. As shown inFIG. 15, the puncture needles 32A and 32B advance toward the inside (thecenter of the first lumen 3) along the guiding portion 91, project fromthe long holes 30, and puncture the portion of the stomach wall that isbeing sucked. Because a space has been established between the abdominalcavity AC and the stomach wall by insufflation, the puncture needles 32Aand 32B puncture only the stomach wall. In addition, the punctureneedles 32A and 32B enter the stomach wall toward the inside followingthe inclination of the guiding portion 91, and thus it is possible tovisually confirm the movement of the puncture needles 32A and 32B, theentrance position, and that the puncture needles 32A and 32B havedefinitely entered the stomach wall by the observation apparatus 55 inthe endoscope 2. In addition, because the distal portion 15 istransparent, the movement of the puncture needles 32A and 32B inside theneedle lumens 92 and 93 can be easily observed.

From this state, the pusher connecting portion 43 is advanced towardsthe needle control handle 41, and the pushers 35 are moved in thedirection of the distal end of the puncture needles 32A and 32B. At thistime, as shown in FIG. 16, the anchors 33A of the two-arm T bar 33 arepushed by the pushers 35 and delivered from inside the puncture needles32A and 32B into the abdominal cavity AC (the exit side of the puncturedtissue). Here, because the hole 37 is oriented from the proximal endside toward the distal end side of the insertion portion 5, the stopper33B of the two-arm T bar 33 is inhibited from falling out when notintended. At this time, because the abdominal cavity AC has beeninsufflated and the space between the abdominal cavity AC and thestomach wall has been established, it is possible to puncture only thestomach wall.

After the anchors 33A of the two-arm T bar 33 are released, the pusherconnecting portion 43 is retracted towards the needle control handle 41to accommodate the pushers 35. Then the puncture needles 32A and 32B areretracted and withdrawn from the stomach wall. At this time, the twoanchors 33A of the two-arm T bar 33 are opened in a T-shape due to thebending of the sutures 33C.

Next, the process proceeds to the incision step (S50). First, after thedistal end of the endoscope 2 is disposed farther toward the proximalside than the accommodating portion 90, the sheath grip portion 40 isgrasped, pulled toward the proximal side, and the puncture needles 32Aand 32B are extracted from the distal end portion 15 (or the overtube1). Because the engagement of the cutting electrode 6 by the punctureneedle 32A is released, the cutting electrode 6 is restored so as totraverse the first lumen 3 due to the elastic force thereof. Note thatthe shape of the cutting electrode 6 may also be restored by moving theelectrode controlling wires 7A and 7B forward and backward. This actionmay also be carried out before the stomach wall suction. Because a spaceis established that is wider than the distal end portion 15 before thestomach wall suction, there is the effect that the cutting electrode 6can be easily restored to the center.

The connection between the connecting terminal 26B of the power cord 28and the connecting terminal 26A of the electrode controlling portion 8is confirmed. Then, while supplying high frequency power from the highfrequency power source 27, the control handle 21 is advanced toward thecontrol body portion 20, and the cutting electrode 6 is projected fromthe distal end portion 15 to abut the stomach wall. At this time,because the cutting electrode 6 is energized via the electrodecontrolling wires 7A and 7B, as shown in FIG. 17 and FIG. 18, thestomach wall is cut open by the cutting electrode 6, and an opening SOis formed in the stomach wall. Note that in this step as well, thesuction on the stomach wall is continued, and thus the retentionposition of the two-arm T bar 33 and the incision position are in anoptimal state.

Next, the process proceeds to a removal step (S60). Here, in order toremove the cutting electrode 6 from the insertion portion 5, thefastening screw 24 on the control body portion 20 of the electrodecontrolling portion 8 is loosened. At this time, the electrodecontrolling wires 7A and 7B are separated from the connecting plate 23,and the electrode controlling wires 7A and 7B are detached. Then, forexample, by grasping and then pulling the end portion of the electrodecontrolling wire 7A toward the distal side, the electrode controllingwire 7A is moved through the inside of the first lumen 3 to the proximalend side, and the electrode controlling wire 7B is moved through theinside of the first lumen 3 to the distal end side. Finally, theelectrode controlling wire 7B also moves to the proximal end side bypassing through the distal end opening of the first lumen 3. In thismanner, the cutting electrode 6 is extracted along with the electrodecontrolling wires 7A and 7B.

Next, the process proceeds to an introduction step (S70). Specifically,as shown in FIG. 19, the endoscope insertion portion 51 of the endoscope2, which is the treatment device, is introduced into the abdominalcavity AC by passing through the opening SO. At this time, when it isnecessary to restrict the relative motion between the insertion portion5 and the endoscope insertion portion 51, an endoscope lock button 47 ispressed to abut the endoscope insertion portion 51, and due to thefriction therebetween, the movement of the endoscope insertion portion51 is prevented. Because the endoscope lock button 47 is provided, it ispossible to inhibit the movement of the endoscope 2 relative to theovertube 1 by operating the endoscope lock button 47, and it is possibleto insert both the overtube 1 and the endoscope 2 into the bodysimultaneously. In addition, because the operation of inserting theendoscope 2 is carried out while holding the proximal handle 44 of theovertube 1, one hand of the operator can support the insertion portion 5of the overtube 1 while the other hand can carry out the operation ofgrasping the proximal handle 44, and thereby the operability is furtherimproved.

When the overtube 1 is introduced into the abdominal cavity AC throughthe opening SO, the retention positions of the anchors 33A of thetwo-arm T bar 33 become more toward the proximal side than the positionof the hole 37 formed in the insertion portion 5. Thereby, the stopper33B accommodated in the hole 37 is pulled in the direction of separationfrom the hole 37 due to the orientation of the hole 37, and the stopper33B drops out of the hole 37.

After positioning, the treatment step (80) is executed in which varioustreatments (medical procedures) such as observation, incision, cellaspiration, suturing or the like are carried out. After carrying out thetreatment, the overtube 1 and the endoscope 2 are removed from theopening SO in the stomach wall.

As shown in FIG. 20, in the suture step (S90), when the endoscope 2 isextracted from the opening SO by a ligating tool 69 that has beeninserted into the channel 60 of the endoscope 2, the large diameterportion 33Ca of the suture 33 is grasped and pulled against the stopper33B of the two-arm T bar 33 that has been retained in advance. In thismanner, the opening SO is sutured. Note that depending on necessity,further suturing is carried out by adding a two-arm T bar 33. At thistime, first because the abdomen is insufflated when the two-arm T bar 33is retained on the stomach wall, suturing by an additional two-arm T bar33 can be carried out easily.

After suturing, the endoscope 2 is removed from the patient, thepressure applied to the abdominal cavity AC is released, and theprocedure is completed.

According to this overtube 1, because a cutting electrode 6 can bedisposed on the distal end side of the insertion portions by traversingthe distal end side of the first lumen 3, when the insertion portion 5is inserted into the stomach ST, it is possible to cut the stomach wallopen without preparing special incision instruments. Because it ispossible to cut a length of tissue equivalent to the length of thecutting electrode 6 that traverses the first lumen 3, it is possible topass the overtube 1 with a light force, and it is possible to inhibitleaks at the outer periphery of the overtube 1 advantageously. Inaddition, because an accommodation portion 90 is provided and thecutting electrode 6 is accommodated so as not to project into the firstlumen 3, the extension and retraction of the device (in this embodiment,the endoscope 2) and the visual field of the observation apparatusprovided on the device can be ensured. Furthermore, because it ispossible to project the device from the distal end of the overtube 1,the character of insertion into the body can be further improved.

Because the electrode controlling wires 7A and 7B can be separated fromthe electrode controlling portion 8, the cutting electrode 6 can beremoved from the insertion portion 5 along with the electrodecontrolling wires 7A and 7B. Therefore, after forming the opening SO,when the endoscope 2 projects from the first lumen 3, the cuttingelectrode 6 is not an obstruction, and when the endoscope 2 passesthrough the first lumen 3, the endoscope 2 can be advanced farther intothe abdominal cavity AC past the tissue that has been cut open.Furthermore, after forming the opening by cutting the tissue, when thedevice (in this embodiment, the endoscope 2) that has passed through thefirst lumen 3 advances to project from the distal end of the overtube 1,the operation of retracting the cutting electrode 6 from the passage ofthe device and the operation of removing the cutting electrode 6 bytemporarily removing the overtube 1 from the body can be omitted. As aresult, it is possible to reduce the time for the procedure up tointroducing the endoscope 2 into the abdominal cavity AC after openingthe stomach wall.

In addition, because the cutting electrode 6 is connected to theelectrode controlling wires 7A and 7B, which can be operated so as toadvance into or retract from the first lumen 3, it is possible for thecutting electrode 6 to be advanced and retracted in the first lumen 3without advancing or retracting the entire insertion portion 5. That is,it is possible to cut by advancing and retracting the cutting electrode6 with respect to the stomach wall by advancing and retracting theelectrode controlling portion 8. At this time, because cutting iscarried out while conducting a high frequency current through thecutting electrode 6, it is possible to cut safely using a light force.

In addition, it is possible to retain the anchors 33A by engaging thesutures 33C before forming the opening by cutting the wall (in thisembodiment, the stomach wall) of the abdominal organs. Here, because thelong hole 30 (the opening through which the puncture needles 32A and 32Bproject) is disposed inside the distal end portion, the operatingconditions of the puncture needles 32A and 32B can be more easilyconfirmed by the observation apparatus provided on the device. Inaddition, because the projection direction of the puncture needles 32Aand 32B is controlled by projecting the puncture needles 32A and 32Balong the guide portions 91 from the long holes 31 toward the front ofthe first lumen 3 in the axial (center axis) L3 direction, it ispossible to insert the puncture needles 32A and 32B into the tissuewhile a space is established between the inner surface of the distal endportion 15 and the position at which the needles 32A and 32B puncturethe tissue. In other words, it is possible to set the entrance positionof the puncture needles 32A and 32B to a portion (farther inside thanthe abutting position 15B of the distal end portion 15) separated fromthe end portion of the tissue that is held inside the first lumen 3 bysuction. Thus, when the puncture needles 32A and 32B are inserted, thetissue (in this embodiment, the stomach wall) is not easily detached. Inthe case of a structure that differs from this embodiment, for example,a structure in which the puncture needles advance and retract fartheroutside (the outer surface side) than the distal end opening or astructure having an opening through which the puncture needles extend orretract in the portion abutting the distal end portion, it is difficultfor the puncture needles to enter the tissue that is being sucked whilethe abutting portion of the distal end portion abuts the tissue. Inaddition, the operational condition of the puncture needles is difficultto confirm. However, in this embodiment, such problems are solved andthe operability is improved.

Furthermore, because the anchors 33A are retained and the sutures 33Cpass through the stomach wall before forming the opening (beforesuturing), when the targeted incision site T is cut open by the cuttingelectrode 6, movement of the tissue is prevented, and thereby cuttingcan be carried out more reliably. In addition, this is possible in astate in which the sutures 33C are only bound during suturing. When theopening is sutured after the medical procedure in the abdominal cavityAC has been completed, it is possible to carry out the suturing of theopening more easily without insulating the stomach, and thereby thesuturing operation becomes easier. Here, when the puncture needles 32Aand 32B are not used, it is possible to accommodate the puncture needles32A and 32B in the needle lumens 92 and 93 formed in the distal endportion 15, and thus the puncture needles 32A and 32B do not interferewhen a device such as the endoscope 2 are being operated.

In addition, because the direction in which the cutting electrode 6traverses the first lumen 3 is perpendicular to the direction at whichthe puncture needles 32A and 32B are joined to the cutting electrode 6,it is possible to separate the puncture position of the puncture needles32A and 32B from the incision location.

Here, modified examples are shown in FIG. 21 and FIG. 22. A notchedportion 101 is formed in the distal portion 15 by cutting a portion ofthe inside periphery that includes the guide portion 91. The notchedportion 101 is formed only in the vicinity of the guide portion 91, butmay extend up to the vicinity of the inner grooves 16 and 17. Due to thenotched portion 101, a larger space can be established the around of thepuncture needles 32A and 32B, or in other words, the space between theentry position of the puncture needles 32A and 32B and the inner surfaceof the distal end portion 15. Because it is possible to suck more tissuein the region around the puncture needles 32A and 32B, there is theadvantage that the tissue does not easily detach during puncture.

Note that in this embodiment, a structure and method were explained inwhich the cutting electrode 6 is accommodated in the accommodationportion 90 by being held back by the puncture needles 32A and 32B.However, in the case that there is a sufficient gap between the overtube1 and the endoscope 2, the cutting electrode 6 may be disposed betweenthe overtube 1 and the endoscope 2 without being accommodated in theaccommodating portion 90, and thus the endoscope 2 may project from theovertube 1 to improve the characteristics of the insertion into thebody.

At this time, because there is a possibility that the cutting electrode6 may be pressed by the endoscope 2 and have a bend imparted theretowhen the endoscope 2 is moved relative to the overtube 1, the cuttingelectrode 6 is accommodated and protected in the electrode tubes 18.Instead, the electrode controlling wires 7A and 7B may be exposed andthe cutting electrode 6 exposed from the electrode tubes 18 and usedonly when cutting tissue (the stomach wall). When done in this manner,it is possible to protect the cutting electrode 6 during insertion intothe body, it is possible to decrease the possibility that a bend will beimparted to the cutting electrode 6, and thereby the shape of thecutting electrode 6 will be in the desired condition while making anincision.

An example of a method in which the cutting electrode 6 is accommodatedin the electrode tubes 18 and exposed while making an incision is todetach one electrode tube 18 from the electrode controlling portion 8and push out the electrode tube 18 while pressing the control handle 21.When done in this manner, only one electrode controlling wire is pressedand exposed from the electrode tubes 18, and at the other electrodecontrolling wire, the cutting electrode 6 is accommodated by beingpressed by the electrode tube 18. When in use, while pulling the controlhandle 21, the electrode tubes 18 are pulled to expose the cuttingelectrode 6, and the electrode tubes 18 are fastened again to theelectrode controlling portion 8. By carrying out the operation in thismanner, the advance and retraction operation (and protection) of thecutting electrode 6 becomes possible.

Second Embodiment

A second embodiment of the present invention will be explained withreference to the drawings.

The second embodiment differs from the first embodiment on the pointthat in this embodiment, as shown in FIG. 23, the overtube 70 provides afirst magnet (magnetic body) 71 that is disposed on the outer peripheralsurface of the insertion portion 5 in proximity to the proximal end ofthe bent portion 13; a second magnet (magnetic body) 72 that is disposedon the outer peripheral surface of the distal end side of the bentportion 13; and a third magnet (magnetic body) 73 that is disposed moretoward the proximal end side (the control handle 21 side) of theinsertion portion 5 than the first magnet 71. Because the enlargement ofthe insertion portion 5 of the overtube 70 is inhibited while the innerdiameter of the first lumen 3 is secured, as shown in FIG. 24, the firstmagnet 71 (identical to the second magnet 72 and the third magnet 73) isdisposed by being partitioned, for example, into magnetic pieces 71A,71B, and 71C at locations other than the locations where the electrodetubes 18 that pass through the insertion portion 5 and the outsidesheath 38 are disposed.

In addition, these magnets 71, 72, and 73 are formed such that the outerperipheral surfaces all have identical magnetic poles. For example, whenthe first magnet 71 is the S-pole, the magnetic poles are alternatelyarranged along the insertion portion 5 such that the second magnet 72and the third magnet 73 are N-poles.

Next, the operation of this embodiment will be explained along with amethod for a medical procedure through a natural orifice shown in theflowchart in FIG. 25 using the overtube 70.

In this embodiment, steps from the insertion step (S10) to the removalstep (S60) identical to those in the first embodiment are executed.

Next, the process proceeds to the introduction step (S100).Specifically, as shown in FIG. 19, the endoscope insertion portion 51 ofthe endoscope 2 is inserted into the abdominal cavity AC through theopening SO.

In addition, as shown in FIG. 26, while the distal end portion 15 of theovertube 70 projects from the opening SO in the stomach ST, a movingmagnet 75 is mounted on the stomach wall AW in proximity to the openingSO such that the magnetic poles of the moving magnet 75 and the secondmagnet 72 of the overtube 70 attract each other. At this time, themoving magnet 75 and the second magnet 72 attract each other. Next, themoving magnet 75 is moved along the abdominal wall AW up to the positionthat the treatment position is located. At this time, the distal endportion 15 moves while being attracted to the moving magnet 75. At thistime, as shown in FIG. 26A, the endoscope insertion portion 51 has beenadvanced beforehand beyond the insertion portion of the overtube 70, andas shown in FIG. 26B, the distal end portion 15 of the overtube 70 maybe advanced along the endoscope insertion portion 51 toward the distalend of the endoscope insertion portion 51 by using the moving magnet 75.In addition, as shown in FIG. 27A, the moving magnet 75 may be movedwhile the endoscope insertion portion 51 is accommodated inside theovertube 70, and as shown in FIG. 27B, the endoscope insertion portion51 may be moved along with the overtube 70.

As shown in FIG. 28, in order to establish the bent shape of the bentportion 13, a stationary magnet 76 is mounted on the abdominal wall AWsuch that the stationary magnet 76 and the first magnet 71 attract eachother. At this time, because the stationary magnet 76 and the firstmagnet 71 attract each other, the bending operation is carried out byoperating the bending control lever 45 while the insertion portion 5 isheld and supported on the abdominal wall AW. Here, when the direction ofthe distal end portion 15 changes while the bent state of the insertionportion 5 is maintained, the support magnets 77A and 77B are mounted onthe abdominal wall AW. Specifically, the support magnet 77A and thefirst magnet 71 attract each other and the support magnet 77B and thethird magnet 73 attract each other. As shown in FIG. 29, when in theserespective attractive states, for example, by fastening the third magnet73 and rotating the first magnet 71 centered on the third magnet 73, thedirection of the distal end portion 15 is changed.

Subsequently, after executing the treatment step (S80), the endoscope 2is returned inside the stomach ST through the opening SO in the stomachwall, removed from the mouth M of the patient PT, and the process movesto the suture step (S90). Then the opening SO in the stomach wall issutured.

After suturing, the endoscope 2 is removed from the patient, thepressure applied to the abdominal cavity AC is released, and theprocedure is completed.

According to this overtube 70, actions and effects identical to those ofthe first embodiment are exhibited. In particular, because the firstmagnet 71, the second magnet 72, and the third magnet 73 are disposedexternally on the insertion portion 5, due to the attraction between themoving magnet 75, the stationary magnet 76, and the support magnets 77Aand 77B, the insertion portion 5 can be supported on the abdominal wallAW. Therefore, it is possible to prevent advantageously the endoscope 2from becoming displaced during treatment while inserted into theovertube 70. In addition, by moving the moving magnet 75, it is possibleto move the distal end direction of the endoscope 2, which has beeninserted into the overtube 70, easily by using the magnets, and therebyit is possible to carry out control of the direction of the endoscope 2easily. In addition, by using the moving magnet 75, the stationarymagnet 76, and the support magnets 77A and 77B, the movement, fastening,and support of the overtube 70 can be carried out from outside the body,and the overtube 70 becomes easier to orient.

Note that the technical scope of the present invention is not limited bythe embodiments described above, and various modifications can be madethat do not depart from the spirit of the present invention.

For example, in the embodiments described above, a flexible endoscopewas used as the observation apparatus. However, this is not limiting,and for example, what is called a capsule endoscope may be retainedinside the body, and while observing the inside of the body using thesame, the desired procedure may be carried out by passing the insertionportion of a treatment device that does not have an observationapparatus through the overtube.

In addition, the number of puncture needles is not limited to two. Fouror six puncture needles may be disposed at predetermined intervals inthe peripheral direction. It is possible to ensure a plurality of suturelocations in the incision direction, and thereby it is possible to carryout the suturing more reliably.

As shown in FIG. 30, a scale 110 may be provided on the side portion ofthe proximal handle 44 along the movement path of the bending controllever 45. By confirming the scale 110, the condition of the bending canbe easily grasped. Furthermore, a scale detecting apparatus 111 may beprovided. The scale detecting apparatus 111 has a first lever 112 and asecond lever 113 disposed so as to surround the operation direction ofthe bending control lever 45. The first lever 112 provides an engagingpiece 112A that can abut the side surface 45A of the curvaturecontrolling levers 45. The second lever 113 provides an engaging piece113A that can abut the other side surface 45B of the bending controllever 45. The respective levers 112 and 113 are provided freelyrotatably coaxial to the bending control lever 45. An example of asupporting structures for the levers 112 and 113 are a rotating axle ofthe bending control lever 45, a tube separately inserted freelyrotatably between the levers 112 and 113 and the cover of the proximalhandle 44, and a flexible member that is fastened in the tube and thatproduces a prescribed frictional force between the levers 112 and 113and the cover of the proximal handle 44.

In FIG. 30, the curvature control lever 45 is inclined at a first angle.From this state, as shown in FIG. 31, when the curvature control lever45 is rotated, the engagement of the first lever 112 with the engagingpiece 112A is released. Because the first lever 112 is providedseparately from the curvature control lever 45 and is supported by aprescribed frictional force on the proximal handle 44, the first lever112 stops and remains at the first angle. Even when the curvaturecontrol lever 45 is returned, it is possible to confirm the first anglefrom the position of the first lever 112.

An example of the usage of such a scale detection apparatus 111 isswitching the endoscope 2 after introducing the overtube 1 and theendoscope 2 into the body and bending them to the first angle. When thebent portion 13 of the overtube 1 is greatly bent (that is, when bent toa small radius of curvature), the bent portion 15 returns temporarily toa gently bent shape or a rectilinear shape, it is then possible toreplace the endoscope 2, and the replacement action can be carried outsmoothly. After inserting a new endoscope 2, if the curvature controllever 45 is returned to the position of the first lever 112, thecurvature angle that was determined first, that is the position of thedistal end portion, can be made again. Note that in the meantime, thesecond lever 113 does not engage with the curvature control lever 45,and stops in the initial position. When the overtube 1 is bent towardthe opposite side, the second lever 113 is operated as described above.

In addition, by operating the curvature control lever 45, the bentportion 13 is provided in two directions (two directions, wherein theinsertion portion 5 is opposite to the substantially rectilinear state).However, two curvature control levers 45 may be provided to enablebending in 4 directions.

As shown in FIG. 32, a needle lumen 120 (second lumen) may be fastenedalong the inner surface that forms the first lumen 3. Puncture needles32A and 32B may each pass so as to be freely extendable and retractablein the needle lumen 120. Because it is possible to enter tissue that isdrawn from the distal end opening of the first lumen 3, effectsidentical to those described above can be obtained. In this case, asshown by the imaginary line in FIG. 32, when a projection shaped ortaper shaped guide portion 125 that projects on the distal end or insideis provided on the inner periphery of the distal end portion 15 on themovement path of the puncture needles 32A and 32B, because the punctureneedles 32A and 32B are urged inside by the guide portion, it ispossible to set the entrance position more toward the center.

1. An overtube comprising: an insertion portion that has a distal endportion and a proximal end portion, and at least the distal end portionthereof is adapted to be inserted into a subject; a first lumen that isformed in the insertion portion and that allows freely inserting andremoving a device for carrying out medical procedures in the subject;puncture needles that pass through the insertion portion, have a controlmember connected to the proximal end portion of the insertion portion,and are adapted to puncture tissue; and one or more second lumensprovided inside the first lumen, through which one or more of thepuncture needles are passed, a distal portion of each of the one or moresecond lumens having an opening at a distal side of the first lumen,wherein the distal portion of each of the one or more second lumens hasa direction with at least a radially inward component.
 2. The overtubeaccording to claim 1, wherein an opening is formed on the distal endportion of the insertion portion so as to communicate with the firstlumen in order to project the device in the forward insertion directionfor insertion into the subject.
 3. The overtube according to claim 1,wherein an abutting portion formed at a distal end of the distal endportion of the insertion portion is adapted to abut the tissue when thetissue of the subject is sucked.
 4. The overtube according to claim 2,further comprising a guide portion that controls the projectiondirection of the puncture needles that project from the openings of thesecond lumens and that makes the puncture needles project in a centerdirection of the first lumen that is in cross-section substantiallyperpendicular to the direction in which the distal end portion of theinsertion portion connects the proximal end portion of the insertionportion.
 5. The overtube according to claim 2, wherein a distal end areaof the second lumens has a passage that angles the puncture needles fromthe proximal end portion to the distal end portion from the innersurface of the distal end portion that forms the first lumen to thedirection of the center axis of the first lumen.
 6. The overtubeaccording to claim 3, wherein each puncture needle has a passage thereinthat can accommodate an anchor that is to be disposed on an exit side ofa punctured tissue.
 7. The overtube according to claim 6, wherein thepuncture needles include a first puncture needle and a second punctureneedle, each of the puncture needles being disposed at opposingpositions across the approximate center of the first lumen.
 8. Theovertube according to claim 7, wherein the anchors accommodated in thefirst puncture needle and the second puncture needle are connectedtogether by a thread, and the distal end has a hole which accommodates astopper portion provided on the thread.
 9. The overtube according toclaim 2, wherein a notched portion is formed in an inside periphery ofthe distal end portion.
 10. The overtube according to claim 2, wherein,at the distal end portion of the insertion portion, the second lumensare formed inside the distal end portion, and centers of the openings ofthe second lumens are formed in the inner side of the distal end portionof the first lumen more towards the proximal side than the opening ofthe insertion portion.
 11. The overtube according to claim 1, whereinthe distal portion of each of the one or more second lumens is offsetwith regard to an axial direction of the first lumen.